Novo Nordisk is a global healthcare company focused on developing treatments for obesity and diabetes, with more than 25 years of research in these areas. Founded in 1923, the company produces medicines intended to support patients across different stages of life and works to strengthen the safety and integrity of its products, including efforts to address falsified medicines. Its work spans pharmaceutical research, patient care, and broader efforts to improve access to essential treatment.
Senior Regulatory Affairs Professional, Novo Nordisk
Lead global regulatory submissions, product labelling and Health Authority strategy for Novo Nordisk medicines. Guide products through development, approval and commercial lifecycle activities across major markets.
Description
- Lead global regulatory strategy for Novo Nordisk products from development through approval and lifecycle management.
- Manage regulatory submissions and engagement with Health Authorities.
- Shape core product labelling to communicate key differentiators.
- Represent Regulatory Affairs on the Global Project Team.
- Use regulatory intelligence to inform strategy and planning.
- Keep the submission plan current in Vault RIM.
- Manage regulatory files—including MAA/NDA/BLA, CTA/IND, device files, PIP/PSP, DSUR/PSUR/RMP, renewals and post-approval changes—from preparation through approval and archiving.
- Plan and lead formal Health Authority meetings, including requests, briefing packages, rehearsals and minutes.
- Develop tCCDS/CCDS, EU and national labelling for new products; support US labelling and maintain labels throughout the product lifecycle.
- Lead regulatory work on the Global Project Team and shape development paths for governance review.
- Chair the RQC Matrix Team, set agendas, prepare input for GPT, GRPT and GRB, and coordinate contributions from CMC, device and labelling sub-teams.
- Advise cross-functional clinical expert groups on regulatory matters, including China-related work.
- Lead worldwide NDA roll-out.
- Set regulatory strategies for commercial products, covering label changes, licence maintenance and other lifecycle activities.
- Cover for other Global Regulatory Leads as needed.
- Raise progress updates, risks and issues early to support timely team decisions.
- Support onboarding, job-shadowing, mentoring and team engagement.
Requirements
- Degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences or a related scientific discipline.
- 12–15+ years of experience in regulatory affairs or closely related work across the pharmaceutical R&D value chain.
- In-depth knowledge of regulatory science and requirements in the EU, US, China, Japan and other regions.
- Practical submission experience in the EU, US, China and Japan.
- Demonstrated experience in lifecycle management, label development, Health Authority interactions, device development and regulatory intelligence.
- Strong project management skills.
- Strong negotiation, stakeholder management and networking skills.
- Ability to build trust across functions and cultures.
- Thorough understanding of the relevant therapy area.
- Proficiency in written and spoken English.
- Ability to adapt as priorities change, identify problems early and make well-founded decisions.
Benefits
- Inclusive recruitment and equal opportunity for all applicants.
- Opportunities to develop skills across the R&D value chain.
- Ownership of professional development.
- Onboarding, job-shadowing and mentoring opportunities.
- Opportunities to contribute to team and department engagement.